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Original Articles

Impact on Health-Related Quality of Life of a Switch From Enfuvirtide to Raltegravir Among Multidrug-Resistant HIV-1–Infected Patients: A Randomized Open-Label Trial (EASIER-ANRS 138)

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Pages 283-293 | Published online: 06 Jan 2015

REFERENCES

  • Lazzarin A, Clotet B, Cooper D, et al. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med. 2003;348:2186–2195.
  • Lalezari JP, Henry K, O'Hearn M, et al. Enfuvirtide, an HIV-1 fusion inhibitor for drug-resistant HIV infection in North and South America. N Engl J Med. 2003;348:2175–2185.
  • Nelson M, Arastéh K, Clotet B, et al. Durable efficacy over 48 weeks in heavily treatment experienced HIV-1-infected patients in the T-20 Versus Optimized Background Regimen Only 1 and 2 clinical trials. J Acquir Immune Defic Syndr 2005;40:404–412.
  • Trottier B, Walmsley S, Reynes J, et al. Safety of enfuvirtide in combination with an optimized background of antiretro-virals in treatment-experienced HIV-1-infected adults over 48 weeks. J Acquir Immune Defic Syndr 2005;40:413–421.
  • Loutfy MR, Harris M, Raboud JM, et al. A large prospec-tive study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration. HIV Med. 2007;8:427–432.
  • Lennox JL, DeJesus E, Lazzarin A, et al. Safety and effi-cacy of raltegravir-based versus efavirenz-based com-bination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised con-trolled trial. Lancet. 2009;374:796–806.
  • Grinsztejn B, Nguyen BY, Katlama C, et al. Safety and efficacy of the HIV-1 integrase inhibitor raltegra-vir (MK-0518) in treatment experienced patients with multidrug-resistant virus: a phase ll randomized controlled trial. Lancet. 2007;369:1261–1269.
  • Steigbigel RT, Cooper DA, Kumar PN, et al. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008;359:339–354.
  • Cooper DA, Steigbigel RT, Gatell JM, et al. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infec-tion. N Engl J Med. 2008;359:355–365.
  • De Castro N, Braun J, Charreau I, et al. Switch from enfu-virtide to raltegravir in virologically suppressed multidrug-resistant HIV-1-infected patients: a randomized open-label trial. Clin Infect Dis. 2009;49:1259–1267.
  • Towner W, Klein D, Kerrigan HL, Follansbee S, Yu K, Horberg M. Virologic outcomes of changing enfuvirtide to raltegravir in HIV-1 patients well controlled on an enfu-virtide based regimen: 24-week results of the CHEER study. J Acquir Immune Defic Syndr 2009;51:367–373.
  • Talbot A, Machouf N, Thomas R, et al. Switch from enfu-virtide to raltegravir in patients with undetectable viral load: efficacy and safety at 24 weeks in a Montreal cohort. J Acquir Immune Defic Syndr 2009;51:362–364.
  • Harris M, Larsen G, Montaner JS. Outcomes of multi-drug-resistant patients switched from enfuvirtide to ralte-gravir within a virologically suppressive regimen. AIDS. 2008;22:1224–1226.
  • Grant PM, Palmer S, Bendavid E, et al. Switch from enfuvirtide to raltegravir in virologically suppressed HIV-1 infected patients: effects on level of residual viremia and quality of life. J Clin ViroL 2009;46:305–308.
  • Sayana S, Prosser P, Ricaurte JC, et al. Analysis of a switch from enfuvirtide to raltegravir in patients with unde-tectable viral load: efficacy and quality of life at 24 weeks [letter]. J Int Assoc Phys AIDS Care. 2009;8:85–86.
  • Campo RE, Cohen C, Grimm K, Shangguan T, Maa J, Seekins D. Switch from protease inhibitor- to efavirenz-based antiretroviral therapy improves quality of life, treat-ment satisfaction and adherence with low rates of virologi-cal failure in virologically suppressed patients. Int J STD AIDS. 2010;21:166–171.
  • Potard V, Chassany O, Lavignon M, Costagliola D, Spire B. Better health-related quality of life after switching from a virologically effective regimen to a regimen containing efavirenz or nevirapine. AIDS Care. 2010;22:54–61.
  • Scott-Lennox JA, Wu AW, Boyer JG, Ware JE Jr. Reliability and validity of French, German, Italian, Dutch, and UK English translations of the Medical Outcomes Study HIV Health Survey. Med Care. 1999;37:908–925.
  • Wu AW, Rubin HR, Mathews WC, et al. A health status questionnaire using 30 items from the Medical Outcomes Study. Preliminary validation in persons with early HIV infection. Med Care. 1991;29:786–798.
  • Burgess A, Dayer M, Catalan J, Hawkins D, Gazzard B. The reliability and validity of two HIV-specific health-related quality-of-life measures: a preliminary analysis. AIDS. 1993;7:1001–1008.
  • Wu AW, Revicki DA, Jacobson D, Mali t FE. Evidence for reli-ability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Qua/ Life Res. 1997;6:481–493.
  • Holmes WC, Shea JA. Two approaches to measuring qual-ity of life in the HIV/AIDS population: HAT-QoL and MOS-HIV. Qua/ Life Res. 1999;8:515–527.
  • Hughes TE, Kaplan RM, Coons SJ, Draugalis JR, Johnson JA, Patterson TL. Construct validities of the Quality of Well-Being Scale and the MOS-HIV-34 Health Survey for HIV infected patients. Med Decis Making. 1997;17:439–446.
  • Wu AW, Hays RD, Kelly S, Malitz F, Bozzette SA. Applica-tions of the Medical Outcomes Study health-related quality of life measures in HIV/AIDS. Qual Life Res. 1997;6:531–554.
  • Wu AW, Rubin HR, Mathews WC, et al. A health status questionnaire using 30 items from the Medical Outcomes Study: preliminary validation in persons with early HIV infection. Med Care. 1991;29:786–798.
  • Cohen CJ, Clumeck N, Molina JM, et al. Health-related quality of life with enfuvirtide (ENF; T20) in combination with an optimized background regimen. J Acquir Immune Defic Syndr 2004;37:1140–1146.
  • Revicki DA, Sorensen S, Wu AW. Reliability and validity of physical and mental health summary scores from the Medical Outcomes Study HIV. Health Survey. Med Care. 1998;36:126–137.
  • Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin EpidemioL 2003;56:395–407.
  • Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remark-able universality of half a standard deviation. Med Care. 2003;41:582–592.
  • Sloan JA, Cella D, Hays RD. Clinical significance of patient-reported questionnaire data: another step toward consensus. J Clin EpidemioL 2005;58:1217–1219.
  • Cohen J. Statistical Power Analysis for the Behavioural Sciences. 2nd ed. Hillsdale, NJ: Erlbaum; 1988.
  • Fairclough DL, Thijs H, Huang IC, Finnern HW, Wu AW. Handling missing quality of life data in HIV clinical trials: what is practical? Qual Life Res. 2008;17: 61–73.
  • Lin MK, Wu AW, Revicki DA. Incorporating quality of life measures in HIV clinical trials. HIV Clin Trials. 2002; 3:202–218.
  • Carpenter JR, Kenward MG. Missing data in randomised controlled trials - a practical guide. 2007. http://www.pcpoh.bham.ac.uk/publichealth/methodology/docs/invitations/Final_Report_RM04_JH17_mk.pdf.
  • Curran D, Molenberghs G, Fayers PM, Machin D. Incom-plete quality of life data in randomized trials: missing forms. Stat Med. 1998;17:697–709.
  • Little RJ, Rubin DB. Statistical Analysis With Missing Data. New York: Wiley; 1987.
  • Wu AW, Gray SM, Brookmeyer R. Application of random effects models and other methods to the analysis of multi-dimensional quality of life data in an AIDS clinical trial. Med Care. 1999;37:249–258.
  • Rothman K. No adjustments are needed for multiple com-parisons. Epidemiology. 1990;1:43–46.
  • Revicki DA, Moyle G, Stellbrink H-J, Barker C. Quality of life outcomes of combination zalcitabine-zidovudine, saquinavir-zidovudine, and saquinavir- zalcitabine-zid-ovudine therapy for HIV-infected adults with CD4 cell counts between 50 and 350 per cubic millimeter. AIDS. 1999;13:851–858.
  • Badia X, Podzamczer D, Moral I, et al. Health-related quality of life in HIV patients switching to twice-daily indi-navir/ritonavir regimen or continuing with three-times-daily indinavir-based therapy. Antivir Ther 2004;9:979–985.

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